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Trial registered on ANZCTR


Registration number
ACTRN12621000641897
Ethics application status
Approved
Date submitted
1/04/2021
Date registered
28/05/2021
Date last updated
4/08/2023
Date data sharing statement initially provided
28/05/2021
Date results information initially provided
12/04/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Biodistribution and radiation dosimetry of a novel gallium-68 radiopharmaceutical for positron emission tomography of cell death in patients with solid malignancies.
Scientific title
Biodistribution and radiation dosimetry of [68Ga]gallium 2,2'-(7-(4-((1-carboxy-4-((1-((carboxymethyl)amino)-3-((2-((4-(dihydroxyarsaneyl)phenyl)amino)-2-oxoethyl)thio)-1-oxopropan-2-yl)amino)-4-oxobutyl)amino)-1-carboxylato-4-oxobutyl)-1,4,7-triazonane-1,4-diyl)diacetate (68Ga NODAGA GSAO) for positron emission tomography (PET) of cell death in patients with solid malignancies.
Secondary ID [1] 300077 0
None
Universal Trial Number (UTN)
U1111-1245-3254
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 315597 0
Condition category
Condition code
Cancer 313890 313890 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive one intravenous injection of 200Mbq of [68Ga]gallium 2,2'-(7-(4-((1-carboxy-4-((1-((carboxymethyl)amino)-3-((2-((4-(dihydroxyarsaneyl)phenyl)amino)-2-oxoethyl)thio)-1-oxopropan-2-yl)amino)-4-oxobutyl)amino)-1-carboxylato-4-oxobutyl)-1,4,7-triazonane-1,4-diyl)diacetate (68Ga NODAGA GSAO). This will be administered by a nuclear medicine specialist or medical radiation scientist.

Following this participants will undergo a total of eight PET scans (during which they will be required to lie still on a scanning bed breathing normally). The first six scans will be performed one after the other commencing at 0, 7, 17, 29, 47 and 65 minutes after 68Ga NODAGA GSAO administration (total duration of approximately 90 minutes). The participant will then have a break and then undergo two further scans commencing at 120 and 180 minutes after 68Ga NODAGA GSAO administration each taking approximately 30 to 40 minutes (with a break in between). Participants will also have also have blood and urine samples collected to determine the amount of 68Ga NODAGA GSAO in blood and excreted in urine. The total duration of the study will be approximately five hours.
Intervention code [1] 316346 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322279 0
The first primary endpoint is to determine the biodistribution of 68Ga NODAGA GSAO assessed by serial PET scan.
Timepoint [1] 322279 0
Biodistribution of 68Ga NODAGA GSAO will be assessed by 8 serial PET scans commencing at 0, 7, 17, 29, 47, 65, 120 and 180 minutes after 68Ga NODAGA GSAO administration. Urine will be collected at 110 and 170 minutes after 68Ga NODAGA GSAO administration to measure excretion. Blood will be collected at 110 and 170 minutes after 68Ga NODAGA GSAO administration to measure radioactivity in blood.
Primary outcome [2] 327383 0
The second primary endpoint is to determine the radiation dosimetry of 68Ga NODAGA GSAO assessed by serial PET scan.
Timepoint [2] 327383 0
Radiation dosimetry of 68Ga NODAGA GSAO will be calculated from the 8 serial PET scans commencing at 0, 7, 17, 29, 47, 65, 120 and 180 minutes after 68Ga NODAGA GSAO administration, from measurements of excreted activity in urine collected at 110 and 170 minutes after 68Ga NODAGA GSAO administration and from measurements of radioactivity in blood collected at 110 and 170 minutes after 68Ga NODAGA GSAO administration.
Secondary outcome [1] 377941 0
The first secondary endpoint is to assess the safety of 68Ga NODAGA GSAO
Timepoint [1] 377941 0
Safety of 68Ga NODAGA GSAO will be assessed by symptom assessment (hourly for 4 hours and then at 1 and 7 days) and ECG, biochemistry and haematological assessment (4 hours and 1 day after 68Ga NODAGA GSAO administration).
Secondary outcome [2] 394881 0
The second secondary endpoint is to assess tumour uptake of 68Ga NODAGA GSAO.
Timepoint [2] 394881 0
Tumour uptake of 68Ga NODAGA GSAO will be measured on the 8 serial PET scans commencing at 0, 7, 17, 29, 47, 65, 120 and 180 minutes after 68Ga NODAGA GSAO administration.

Eligibility
Key inclusion criteria
Patients must be able to understand and willing to sign the written informed consent
Male or female patients greater than or equal to 18 years of age
Histologically or cytologically confirmed solid malignancy with at least one measurable lesion greater than 2 cm
Adequate liver function (bilirubin less than or equal to 1.5 upper limit normal (ULN), ALT and AST less than or equal to 4 ULN)
Adequate renal function (eGFR greater than less than or equal to 50 ml/min/1.73m2)
Adequate bone marrow function (absolute neutrophil count greater than or equal to 1.5 x 10^9/l, haemoglobin level greater than or equal to 9.0 g/dl and platelets greater than or equal to 100 ×x 10^9/l).
Serum potassium greater than or equal to 3.0mmol/l and magnesium greater than or equal to 0.6mmol/l
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cancer treatment within the previous 6 weeks
Primary or isolated metastatic CNS malignancy
Active uncontrolled infection
Congestive heart failure or prior NYHA class III-IV cardiac disease
Uncontrolled hypertension (systolic BP > 180mmHg or diastolic BP >100mmHg)
Evidence of recent heart disease (myocardial infarction in the past 2 months by ECG, arrhythmias associated with QTc prolongation or evidence of ischemia)
Evidence of QTc > 480 ms
Medications that prolong QTc
Pregnancy
Breast feeding

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis
Bio distribution of 68Ga NODAGA GSAO in normal tissues and tumour will be determined by measurement of activity within volumes of interest on the PET scan
Absorbed radiation dose will be calculated using OLINDA/EXM
Adverse events will be recorded as a tabulated list

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
24/08/2018
Date of last participant enrolment
Anticipated
30/06/2022
Actual
16/10/2020
Date of last data collection
Anticipated
30/09/2022
Actual
23/10/2020
Sample size
Target
8
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 15460 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 28813 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 304524 0
University
Name [1] 304524 0
University of Sydney
Country [1] 304524 0
Australia
Primary sponsor type
Hospital
Name
Prince of Wales Hospital
Address
Prince of Wales Hospital
Barker Rd, Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 309053 0
None
Name [1] 309053 0
Address [1] 309053 0
Country [1] 309053 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304955 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 304955 0
G71 East Wing Edmund Blacket Building,
Prince of Wales Hospital,
Barker Rd, Randwick NSW 2031
Ethics committee country [1] 304955 0
Australia
Date submitted for ethics approval [1] 304955 0
Approval date [1] 304955 0
10/11/2017
Ethics approval number [1] 304955 0
17/245 (HREC/17/POWH/536)

Summary
Brief summary
68Ga NODAGA GSAO is a new radioactive compound that when injected allows a different type of PET scan to be performed to directly image dead and dying cells. This study aims to determine how 68Ga GSAO is taken up by both cancer and non-cancer cells in a small group of cancer patients.

Who is it for?
You may be eligible for this study if you are aged 18 or older, you have a histologically or cytologically confirmed solid cancer with at least one measurable lesion >2 cm and you meet pre-specified requirements for liver and renal function. Please note that patients with primary or metastatic brain or spinal cancer will not be eligible for this study.

Study details
Participants who choose to enrol in this study will be injected with 68Ga NODAGA GSAO and following this they will undergo a total of eight PET imaging scans (during which they will be required to lie still on a scanning bed breathing normally). The first six scans will be performed one after the other (total duration of approximately 90 minutes). Participants will then have a break and then undergo two further scans each taking approximately 30 to 40 minutes (with a break in between). Participants will also have blood and urine samples collected to determine the amount of 68Ga NODAGA GSAO in blood and excreted in urine. The total duration of the study will be approximately five hours.

Patients will also be followed up for 7 days after 68Ga NODAGA GSAO PET scanning to determine if they have experienced any side effects from the injection.

It is hoped this research may be used to improve health outcomes for future cancer patients by investigating the safety and usefulness of the 68Ga NODAGA GSAO PET scan to image cancer cell death as a way of determining cancer treatment response earlier and more accurately than currently available imaging methods.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98762 0
Dr Ivan Ho Shon
Address 98762 0
Department of Nuclear Medicine and PET
Level 2 Campus Centre
Prince of Wales Hospital
Barker Rd, Randwick NSW 2031
Country 98762 0
Australia
Phone 98762 0
+61 2 93822239
Fax 98762 0
Email 98762 0
i.hoshon@unsw.edu.au
Contact person for public queries
Name 98763 0
Dr Ivan Ho Shon
Address 98763 0
Department of Nuclear Medicine and PET
Level 2 Campus Centre
Prince of Wales Hospital
Barker Rd, Randwick NSW 2031
Country 98763 0
Australia
Phone 98763 0
+61 2 93822200
Fax 98763 0
Email 98763 0
i.hoshon@unsw.edu.au
Contact person for scientific queries
Name 98764 0
Dr Ivan Ho Shon
Address 98764 0
Department of Nuclear Medicine and PET
Level 2 Campus Centre
Prince of Wales Hospital
Barker Rd, Randwick NSW 2031
Country 98764 0
Australia
Phone 98764 0
+61 2 93822200
Fax 98764 0
Email 98764 0
i.hoshon@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA first-in-human study of [68Ga]Ga-CDI: a positron emitting radiopharmaceutical for imaging tumour cell death.2022https://dx.doi.org/10.1007/s00259-022-05880-z
N.B. These documents automatically identified may not have been verified by the study sponsor.